Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

This study has been terminated.
(Administrative reasons.)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00315458
First received: April 17, 2006
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.


Condition Intervention Phase
Osteoarthritis
Drug: Buprenorphine transdermal patch
Drug: Placebo transdermal patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 483 days ] [ Designated as safety issue: Yes ]
    For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.


Enrollment: 107
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTDS
Buprenorphine transdermal patches 10 or 20 mcg/h
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
Drug: Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.

Detailed Description:

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
  • taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

  • requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
  • scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315458

  Show 48 Study Locations
Sponsors and Collaborators
Purdue Pharma LP
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00315458     History of Changes
Obsolete Identifiers: NCT01137279
Other Study ID Numbers: BUP3011 and BUP3011S
Study First Received: April 17, 2006
Results First Received: July 28, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
osteoarthritis
opioid
transdermal

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on July 31, 2014